Home » FDA Issues More Product-Specific Bioequivalence Guidances
FDA Issues More Product-Specific Bioequivalence Guidances
The FDA has released 23 new draft guidances and revised draft product-specific guidances that detail its recommendations for bioequivalence studies to support ANDAs. Comments on the recommendations are due by Feb. 15.
Generic Line
Generic Line
Upcoming Events
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May